Body contouring model Body Contouring Improve your body & your life

Body Contouring Gastric Balloon Clinical Trial

Orbera Clinical Trial

Diagram of gastric balloon in stomach

In the U.S. pivotal ORBERA™ clinical trial, a multicenter, prospective, randomized, non-blinded comparative study, patients suffering from obesity with a BMI between 30 and 40 were randomized to treatment or control in a 1:1 ratio. The treatment group underwent placement of the Orbera balloon followed by removal after 6 months. They concurrently participated in a 12-month behavioral modification program. The control group participated in the 12-month behavioral modification program alone. For patients in the treatment group, the device was removed at month 6, with regular office visits continuing through 1 year.

A total of 125 patients were randomized to the treatment group and 130 patients were randomized to the control group.

Detailed findings from the trial include:

  • At month 6, the Orbera group achieved a mean of 38.4% Excess Weight Loss (EWL).
  • Mean Total Body Weight Loss (TBWL) at 6 months was 10.2% for the treatment group compared to 3.3% TBWL for the control group.
  • The Orbera group lost 3.1 times as much weight as the control group at 6 months.
  • The Orbera group also lost significantly more weight than the control group over the course of the study, and was able to maintain significant weight loss through month 12, 6 months after removal of the device.

Birmingham, AL Office & Surgery Suite

Hedden Plastic Surgery 140 Village Street
Birmingham, AL 35242 205-980-1744 or 800-HeddenMD Map & Directions

Hedden Plastic Surgery logo

Contact Us Today

Questions About Body Contouring?

To learn more about shaping up with the gastric balloon in Birmingham, AL, please contact Hedden Plastic Surgery today.

please complete all fields